Sr. Principal Medical Writer - Regulatory Submission Docs

Responsibilities

• Develop regulatory documents for global submission in line with ICH guidelines and timelines

• Manage medical writing projects and communicate with cross-functional teams on review cycles

• Participate in cross-functional meetings and process improvement initiatives

• Review protocols and statistical analysis plans as appropriate

• Define and write standard operating procedures and best practices

• Manage internal and contract medical writing resources

• Mentor more junior medical writing staff

Requirements

• Bachelor's degree required

• At least 5 years of medical writing experience in biopharma or CRO industry

• Strong organizational, time management and project management skills

• Strong verbal, written and interpersonal communication skills

• Proficient understanding of global regulatory requirements

• Proficient in MS Word

• Experience with electronic document management systems and templates

Preferred Qualifications

• Oncology experience

• Advanced degree in a relevant scientific, clinical or regulatory field

• Knowledge of therapeutic areas across clinical development phases

Benefits

• Career development and progression

• Total rewards program

• Technical and therapeutic area training

About the Company

• Syneos Health is a fully-integrated life sciences services organization accelerating customer success across drug development and commercialization.